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Effect of aerobic training and vitamin D supplementation on liver Fat, liver enzymes and lipid profile in elderly women with nonalcoholic fatty liver and vitamin D deficiency

Protocol summary

Study aim
Evaluation of the interactional effects of 8 weeks of vitamin D supplementation and aerobic training on the fatty liver level, serum levels of liver enzymes (ALT and AST), lipid profile, and body composition in elderly women with Nonalcoholic fatty liver and vitamin D deficiency
Design
Clinical trials with a control group, and purposive sampling model
Settings and conduct
This clinical trial study will be conducted on the effects of aerobic training with Vit D supplementation on NAFLD patients in pre-test and post-test form.
Participants/Inclusion and exclusion criteria
Inclusion criteria will be include ultrasound (US) confirmation of being in second or third grade of NAFLD and certified by an internist, 25-OHD serum levels between 10 and 20 ng/ml, not having a specific diet and regular exercise program in the past year. Exclusion criteria include; significant consumption of alcohol more than 20 gr per day, presence of other liver diseases (B and C hepatitis), other disorders such as autoimmune hepatitis and ..., also surgical treatment of obesity or severe weight loss, and the presence of any other chronic disease or skeletal disorders
Intervention groups
Aerobic training (placebo); Vitamin D supplementation (no AT); Aerobic training with vitamin D supplements (AT+Vit D); and Control (placebo+no AT).
Main outcome variables
Vitamin D levels, liver fat levels, serum levels of liver enzymes, lipid profiles, body composition, blood pressure, insulin, glucose

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190423043359N1
Registration date: 2019-08-15, 1398/05/24
Registration timing: retrospective

Last update: 2019-08-15, 1398/05/24
Update count: 0
Registration date
2019-08-15, 1398/05/24
Registrant information
Name
Zahra Hoseini
Name of organization / entity
Razi University, Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 3423 3267
Email address
zahra.hoseinir@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-12, 1397/09/21
Expected recruitment end date
2019-01-11, 1397/10/21
Actual recruitment start date
2018-12-12, 1397/09/21
Actual recruitment end date
2019-01-11, 1397/10/21
Trial completion date
2019-03-19, 1397/12/28
Scientific title
Effect of aerobic training and vitamin D supplementation on liver Fat, liver enzymes and lipid profile in elderly women with nonalcoholic fatty liver and vitamin D deficiency
Public title
Effect of aerobic training and vitamin D supplementation on liver Fat, liver enzymes and lipid profile
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Ultrasound (US) confirmation of being in second or third grade of NAFLD and certified by an internist 25-OHD serum levels between 10 and 20 ng/ml Being in second or third grade of NAFLD Not having a specific diet and regular exercise program in the past year
Exclusion criteria:
Significant consumption of alcohol more than 20 gr per day Presence of other liver diseases (B and C hepatitis) Other disorders such as autoimmune hepatitis, joint disease, celiac and Wilson disease, coronary artery disease, kidney failure, hypothyroidism Surgical treatment of obesity or severe weight loss Presence of any other chronic disease or skeletal disorders
Age
From 60 years old to 65 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Forty subjects will be randomly divide into four groups includes Aerobic training (AT, n=10); Vitamin D supplementation (Vit D, n=10); Aerobic training with vitamin D supplements (AT+Vit D, n=10); and control (C, n=10) using statistical software. Each participant will have an equal chance of being in each group, and researchers and participants in the study will not be able to predict the type of intervention they receive.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
No. 8, Beheshti Blvd, Kermanshah Province, Kermanshah University of Medical Sciences.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-03-06, 1397/12/15
Ethics committee reference number
IR.KUMS.REC.1397.1059

Health conditions studied

1

Description of health condition studied
Non-alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
liver fat levels
Timepoint
Evaluation of fatty liver grade prior to the intervention and 24-48 h after intervention finished
Method of measurement
Using ultrasound (US)

2

Description
Vitamin D levels
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By blood sampling

3

Description
Anthropometric indices
Timepoint
Before the study starts and after the study ends
Method of measurement
Using INBODY test

4

Description
Lipid profile
Timepoint
Before the study starts and after it ended.
Method of measurement
Blood sampling

5

Description
serum levels of liver enzymes
Timepoint
Before the study starts and after it ended.
Method of measurement
Blood sampling

6

Description
glucose and insulin levels
Timepoint
Before the study starts and after it ended.
Method of measurement
Blood sampling

7

Description
blood pressure
Timepoint
Before the study starts and after it ended.
Method of measurement
Digital sphygmomanometer

Secondary outcomes

empty

Intervention groups

1

Description
The aerobic training + vitamin D supplementation Intervention will be consists of 20-40 minutes of aerobic exercise at 60% - 75% of HRmax, 3 times a week for eight weeks and vitamin D supplementation will be receiving vitamin D (∼50000 IU • week for eight weeks).
Category
Lifestyle

2

Description
Intervention group: Aerobic training consists of 20-40 minutes of aerobic exercise at 60% - 75% of HRmax, 3 times a week for eight weeks.
Category
Lifestyle

3

Description
Intervention group: Vitamin D supplementation includes receiving vitamin D (∼50000 IU • week for eight weeks).
Category
Lifestyle

4

Description
Control group: receiving placebo and no aerobic training for eight weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam hosein hospital
Full name of responsible person
Zahra hoseini
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3428 3272
Fax
+98 83 3428 3272
Email
zahra.hoseinir@gmail.com
Web page address
http://www.ehmc.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Nasser behpour
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3428 3272
Fax
+98 83 3428 3272
Email
publicrelation@razi.ac.ir
Web page address
https://razi.ac.ir/
Grant name
no
Grant code / Reference number
00000000000000000000000000000000000000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University
Proportion provided by this source
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Razi University
Full name of responsible person
Rastegar Hoseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3428 3272
Fax
+98 83 3428 3272
Email
Rastegar.hoseini@gmail.com
Web page address
https://phe.razi.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University
Full name of responsible person
Rastegar Hoseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Bagh-abrisham Blvd, Razi University
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 988334233267
Email
Rastegar.hoseini@gmail.com
Web page address
https://phe.razi.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Razi University, Kermanshah
Full name of responsible person
Zahra Hoseini
Position
MSc Student
Latest degree
Master
Other areas of specialty/work
Others
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714988935
Phone
+98 83 3423 3267
Fax
Email
zahra.hoseinir@gmai.com
Web page address
https://phe.razi.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data will be record in the SPSS software and will be available.
When the data will become available and for how long
Availability will start nine months after publishing all papers
To whom data/document is available
Only available for researchers in academic and scientific institutions
Under which criteria data/document could be used
All data can be used as reference
From where data/document is obtainable
Zahra.hoseinir@gmail.com
What processes are involved for a request to access data/document
If the explanation for data request would be convincing it will be given in 3 days.
Comments
not having any
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